HON. RON PAUL OF TEXAS
BEFORE THE US HOUSE OF REPRESENTATIVES
March 22, 2004
Dont Let the FDA Block Access to Needed Health Care Information
2004 Ron Paul 20:1
Mr. Speaker, I rise
to introduce the Health Information Independence Act. This Act restores
the
right of consumers to purchase the dietary supplements of their choice
and
receive accurate information about the health benefits of foods and
dietary
supplements. The Act restricts the Food and Drug Administration’s power
to
impede consumers access to truthful claims regarding the benefits of
foods and
dietary supplements to those cases where the FDA has evidence that a
product
poses a threat to safety and well-being, or that a product does not
have a
disclaimer informing consumers that the claims are not FDA-approved.
2004 Ron Paul 20:2
Claims
that could
threaten public safety, or that are marketed without a disclaimer,
would have to
be reviewed by an independent review board, comprised of independent
scientific
experts randomly chosen by the FDA. Anyone who is (or has been) on the
FDAs
payroll is disqualified from serving on the board.
The FDA is forbidden from exercising any influence over the
review board.
If the board recommends approval of a health claim, then the FDA must
approve
the claim.
2004 Ron Paul 20:3
The
board also must
consider whether any claims can be rendered non-misleading by adopting
a
disclaimer before rejecting a claim out of hand. For example, if the
board finds
the scientific evidence does not conclusively support a claim, but the
claim
could be rendered non-misleading if accompanied with a disclaimer, then
the
board must approve the claim- provided it is always accompanied by an
appropriate disclaimer. The disclaimer would be a simple statement to
the effect
that “scientific studies on these claims are inconclusive” and/or
“these
claims are not approved by the FDA.” Thus, the bill tilts the balance
of
federal law in favor of allowing consumers access to information
regarding the
health benefits of foods and dietary supplements, which is proper in a
free
society.
2004 Ron Paul 20:4
The
procedures
established by the Health Information Independence Act are a fair and
balanced
way to ensure consumers have access to truthful information about
dietary
supplements. Over the past decade, the American people have made it
clear they
do not want the federal government to interfere with their access to
dietary
supplements, yet the FDA continues to engage in heavy-handed attempts
to
restrict such access.
2004 Ron Paul 20:5
In
1994, Congress
responded to the American peoples desire for greater access to
information
about the benefits of dietary supplements by passing the Dietary
Supplements and
Health and Education Act of 1994 (DSHEA), liberalizing rules regarding
the
regulation of dietary supplements. Congressional offices received a
record
number of comments in favor of DSHEA.
2004 Ron Paul 20:6
Despite
DSHEA, FDA
officials continued to attempt to enforce regulations aimed at keeping
the
American public in the dark about the benefits of dietary supplements.
Finally,
in the case of Pearson v. Shalala, the United States Court of Appeals
for the DC
Circuit Court reaffirmed consumers First Amendment right to learn
about dietary
supplements without unnecessary interference from the FDA. The Pearson
decision
anticipated my legislation by suggesting the FDA adopt disclaimers in
order to
render some health claims non-misleading.
2004 Ron Paul 20:7
In
the years since
the Pearson decision, members of Congress have had to continually
intervene with
the FDA to ensure it followed the court order. The FDA continues to
deny
consumers access to truthful health information. Clearly, the FDA is
determined
to continue to (as the Pearson court pointed out) act as though
liberalizing
regulations regarding health claims is the equivalent of “asking
consumers to
buy something while hypnotized and therefore they are bound to be
misled.
2004 Ron Paul 20:8
The
FDA’s
“grocery store censorship” not only violates consumers’ First Amendment
rights- by preventing consumers from learning about the benefits of
foods and
dietary supplements, the FDA’s policies are preventing consumers from
taking
easy steps to improve their own health!
2004 Ron Paul 20:9
If
Congress is
serious about respecting First Amendment rights, and the people’s right
to
improve their own health, we must remove the FDA’s authority to censor
non-misleading health claims, and claims that can be rendered
non-misleading by
the simple device of adopting a disclaimer.
2004 Ron Paul 20:10
In
conclusion, I urge
my colleagues to help establish an objective process that respects
consumers
First Amendment rights to non-misleading information regarding the
health
benefits of foods and dietary supplements by cosponsoring the Health
Information
Independence Act.